Neurotoxicity of Generic Anesthesia Agents in Infants and Children: An Orphan Research Question in Search of a Sponsor

This Viewpoint argues that more studies and trials are needed to address questions about the optimal dose, duration, and frequency of use of anesthetic agents and vulnerable periods of exposure in young children.

Millions of neonates and toddlers undergo anesthesia or sedation for surgeries and procedures each year. At the same time, mounting evidence from controlled studies in young animals suggests that anesthetic agents, administered during vulnerable periods, have neurotoxic effects that result in long-lasting deficits in learning and cognitive behavior. The relevance of these animal models to humans is unclear, and the available observational studies in children are limited. However, the possibility of harm exists. On November 19, 2014, the US Food and Drug Administration (FDA) Science Board, which provides advice to the FDA commissioner, was asked to evaluate whether the emerging data “are sufficient to conclude that the adverse effects noted in juvenile animals are reasonably expected to also occur in developing humans.”1